A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy
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ClinicalTrials.gov Identifier: NCT03084861 |
Recruitment Status :
Terminated
(Low recruitment. No safety issue associated.)
First Posted : March 21, 2017
Last Update Posted : October 27, 2020
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Condition or disease | Intervention/treatment | Phase |
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Neurotrophic Keratopathy | Drug: Cord Blood Eye Drops Drug: Conventional treatment | Phase 1 Phase 2 |
This is a multicenter, randomized, open-label, two-arms phase I/II, clinical trial, in which 42 patients will be enrolled with the principal objective to evaluate the efficacy through changes in lesion size and, secondary, to evaluate the safety and efficacy through corneal sensibility, corneal opacity, visual acuity and complications of NK. Patients will be randomized 1:1 to receive experimental treatment (cord blood eye drops) or conventional treatment (artificial tears and therapeutic contact lens).
All patients, with conventional or experimental treatment, will be treated for 19 days. A topical antibiotic will be added too as a concomitant treatment to all treatment groups, until the injury closes or according to medical criteria.
After signing informed consent, inclusion and exclusion criteria will be assessed, and if the patient meets all the requirements, the patient will be randomized.
After initiation of the treatment, patients will be follow-up at 2-3 days and once a week for 3 weeks. A final follow-up is planned at 6 weeks.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | open label |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Open-label, Two-arms Phase I/II Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy |
Actual Study Start Date : | February 24, 2017 |
Actual Primary Completion Date : | March 12, 2020 |
Actual Study Completion Date : | March 12, 2020 |
Arm | Intervention/treatment |
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Experimental: cord blood eye drops
Experimental drug: cord blood eye drops Description: eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives Dosage regimen: 1 drop every 2 hours Pharmaceutical form: ophthalmic preparation eye drops Presentation: batch of 19 vials of 1 mL per vial Route of administration: ophthalmic/ocular
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Drug: Cord Blood Eye Drops
Eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives |
Active Comparator: Conventional treatment
Conventional treatment:
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Drug: Conventional treatment
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- Corneal lesion size [ Time Frame: after 3 weeks post-treatment, ]Variation percentage in corneal lesion size
- Incidence of Adverse Events [ Time Frame: From date of randomization until the date of the last visit (6 weeks post-treatment) ]Safety evaluation through laboratory data and adverse events
- Corneal lesion size [ Time Frame: at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment ]Variation percentage in corneal lesion size
- Stage on the corneal lesion [ Time Frame: at 3 weeks post-treatment ]Changes stage on the corneal lesion (cured, stage 1, stage 2, stage 3) from baseline
- Qualitative scale of corneal sensibility [ Time Frame: at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment ]Changes in qualitative scale of corneal sensibility (normoesthesia, hypoesthesia, anesthesia)
- Corneal opacity [ Time Frame: at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment ]Changes on corneal opacity from baseline (not response, improvement, worse)
- Visual acuity [ Time Frame: at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment ]Line variation in relation to visual acuity
- Neurotrophic keratopathy [ Time Frame: From date of randomization until the date of the last visit (6 weeks post-treatment) ]Number of neurotrophic keratopathy complications

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18 years old
- NK stage 2 or 3 (Mackie classification)
- Signed Informed Consent Form
- The patient is able to understand the nature of the study and to participate throughout its duration
Exclusion Criteria:
- Medical history of eye tumors
- Active eye infection
- Eyelid bad position or eyelid closure problems
- Conjunctiva scarring
- Topic chronic eye treatments with corticoids
- Acute corneal burns (<3 months)
- Intolerance to contact lens
- Allergy or inability to receive concomitant treatment with Exocin®
- Patients with immunosuppressive or chemotherapy treatment
- Pregnant woman or woman without proper contraceptive methods according to the investigator (*), or lactating women
- Participation in another clinical trial in the last month (*) Contraceptive methods accepted in the protocol are: hormonal, intrauterine device (IUD), barrier methods, voluntary sterilization or the patient has menopause >1 year duration

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084861
Spain | |
Hospital Universitari Germans Trias i Pujol | |
Badalona, Barcelona, Spain, 08916 | |
Hospital Mútua de Terrassa | |
Terrassa, Barcelona, Spain, 08221 | |
Hospital de la Santa Creu i Sant Pau | |
Barcelona, Catalonia, Spain, 08026 | |
Hospital Vall d'Hebron | |
Barcelona, Catalonia, Spain, 08035 | |
Instituto Oftalmológico Quirónsalud Barcelona | |
Barcelona, Spain, 08017 | |
Hospital de l'Esperança | |
Barcelona, Spain, 08024 | |
Institut de microcirurgia ocular IMO | |
Barcelona, Spain, 08035 | |
Hospital Clinic i Provincial de Barcelona | |
Barcelona, Spain, 08036 | |
Hospital Josep Trueta | |
Girona, Spain, 17007 | |
Hospital Joan XXIII | |
Tarragona, Spain, 43005 |
Principal Investigator: | Sergi Querol Giner, MD PHD | Banc de Sang i Teixits |
Responsible Party: | Banc de Sang i Teixits |
ClinicalTrials.gov Identifier: | NCT03084861 |
Other Study ID Numbers: |
I.2016.010 |
First Posted: | March 21, 2017 Key Record Dates |
Last Update Posted: | October 27, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Ophthalmic Solutions Pharmaceutical Solutions |